Have you heard about this new fast and easy way to screen for breast cancer? If you have – don’t fall for it. A protocol of regular mammograms is still your best bet for early detection of breast cancer.
As women, we all know about Pap tests, right? You get them every few years, as part of your regular physical; they reveal early signs of cervical cancer.
Enter the “breast Pap test,” which uses a medical screening device currently offered to doctors by Halo Healthcare, Inc., a California company. This test withdraws fluid from a woman’s breast – usually her milk ducts – and checks the fluid for signs of atypical cells, cells that might one day develop into cancer cells.
Sounds good, right? Just as your Pap test protects you against cervical cancer, this new test will protect you against breast cancer – without having to go through the hassle and potential pain of a mammogram.
Well, not so fast.
The cervical Pap test (named after Dr. George Papanicolaou, its inventor), has been around since the 1920s, and has seen wide usage since the 1940s. (Shepard, 2011) There are decades of data supporting its efficacy as a cervical cancer screening tool.
The “breast Pap test” (a.k.a. nipple aspiration), however, has been available to women for just over 10 years. And at this point, it’s not approved for use as a breast cancer screening tool.
Why not? Because there’s no evidence that it works.
To start with, the device is only able to aspirate breast fluid from patients about half the time. And even when fluid is successfully collected, researchers have been unable to show that examining this fluid either helps inform good clinical decision-making around breast health; or reduces breast cancer mortality. ("Cytological examination of," 2013)
The issue is, finding atypical cells in a woman’s breast doesn’t mean she has cancer. Nor do atypical cells mean a woman will develop cancer. Many women go through life with atypical cells in their breast; some even develop pre-cancerous lesions.
But it’s estimated less than half of women with a pre-cancer (DCIS) ever actually see it become a true, invasive cancer. And if those cells do eventually become cancerous, chances are excellent the growing tumor will be identified (via mammography) long before it becomes potentially dangerous. Thus, finding atypical cells isn’t really actionable information for doctors, or their patients.
Think of it like this: you’re looking at the sky on a sunny day, and you spot a puffy white cloud. You decide a tornado is on the way, so you’d best take shelter in the closet in the basement – perhaps for years, until there are no longer any clouds in the sky. It’s just not reasonable.
Nevertheless, nipple aspiration testing equipment continues to be made available to doctors, who continue to purchase it – perhaps truly believing in its worth, lack of evidence notwithstanding.
Or perhaps, as some intimate, simply to make money off of worried patients: the test costs $100, and isn’t covered by insurance. (Shute, 2013)
On December 12, 2013, the FDA issued the following “safety communication:”
“The FDA is alerting the public, including women and health care providers, that a nipple aspirate test is not a replacement for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself to screen for or diagnose breast cancer. The FDA is not aware of any valid scientific data to show that a nipple aspirate test by itself is an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease.” ("FDA safety communication," 2013)
The National Comprehensive Cancer Network, a not-for-profit alliance of 23 of the world's top cancer centers, has also failed to endorse the test, saying it shouldn’t be used for breast cancer screening.
You may not enjoy having an annual mammogram, but don’t trust your health (and possibly your life) to an unproven test. If you’re determined to try nipple aspiration, be sure you back it up with a mammogram – still the gold standard for early detection of breast cancer.
Cytological examination of breast fluids for cancer screening. (2013, August 01). Retrieved from https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools and Resources/Policies and Protocols/Medical Policies/Medical Policies/Cytological_Exam_Breast_Fluids_for_CA.pdf
FDA safety communication: Breast cancer screening - nipple aspirate test is not an alternative to mammography. (2013, December 12). Retrieved from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm378389.htm
Millburg, S. (2013, December 19). FDA: Nipple aspirate no sub for mammogram. Retrieved from http://www.radiologydaily.com/daily/breast-imaging/fda-nipple-aspirate-no-sub-for-mammogram/
Shepard, E. (2011, June 29). George Papanicolaou: Development of the pap smear. Retrieved from http://weill.cornell.edu/archives/blog/2011/06/george-papanicolaou-development-of-the-pap-smear.html
Shute, N. (2013, December 13). FDA warns against test touted as mammogram alternative. Retrieved from http://www.npr.org/blogs/health/2013/12/13/250717703/nipple-aspiration-fda-warns-against-test-touted-as-mammogram-alternative
Published On: February 26, 2014